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Prosthetic Complications and Patient Satisfaction of Two Different Implant Distribution

Prosthetic Complications and Patient Satisfaction of Two Different Implant Distribution for Stress Free Implant Bar Mandibular Overdenture:

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07400380
Enrollment
30
Registered
2026-02-10
Start date
2024-07-02
Completion date
2025-10-05
Last updated
2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Satisfaction, Prosthetic Complication

Keywords

implant overdenture, bar attachment, patient satisfaction

Brief summary

Purpose: This clinical study aimed to evaluate patient satisfaction and prosthetic complications of different distributions of four implants supported mandibular overdentures using Stress free implant bar (SFI-Bar attachments). Evaluation was done for patient satisfaction and prosthetic complications

Detailed description

Purpose: This clinical study aimed to evaluate patient satisfaction and prosthetic complications of different distributions of four implants supported mandibular overdentures using Stress free implant bar (SFI-Bar attachments). Materials and Methods: thirty completely edentulous patients with insufficient retention and stability of their conventional mandibular denture were eligible for this study. All patients received new maxillary and mandibular dentures. The patients were randomly divided into three groups. (G1): four implants were distributed in interforaminal distance, 2-Implant were inserted in canine region and 2- implant 8mm posterior to canine implants. (G2): 4-implants were distributed in quadrilateral distribution, 2-Implant in canine region and 2-Implant were inserted 26mm posterior to canine implant. Patient satisfaction was evaluated by visual analogue scale and prosthetic complications were evaluated on the patient level and implant patients.

Interventions

PROCEDUREfour implants inserted in the mandible and distributed in quadrilateral manner and SFI-Bar had been inserted

Implant positions were planned at canines for both groups. (Intraforaminal): posterior implants are 8 mm posterior to the canine implants \[minimum allowed inter-implant distance for SFIbars (Quadrilateral): posterior implants are 26 mm posterior to the canine implants \[Maximum allowed inter-implant distance for SFI-bars

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

Group 1: four implants were distributed in interforaminal distance, 2-Implant were inserted in canine region and 2-implant 8mm posterior to canine implants. Group 2: four implants were distributed in quadrilateral distribution, 2-Implant in canine region and 2-Implant were inserted 26mm posterior to canine implant.

Eligibility

Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

Normal jaw relation Good oral hygiene Patient with class I or class II inter-rach space.

Exclusion criteria

Patients with TMJ disorder and heavy smokers for more than 10 cigarettes per day. Uncooperative patient. Unfavorable occlusion. Limited restoration space (less than 12 mm).

Design outcomes

Primary

MeasureTime frameDescription
patient satisfactionone yearA visual analog scale (VAS) and oral health-related quality of life (OHRQoL) were used for evaluating patient satisfaction. Participants in the VAS were instructed to draw a vertical line anywhere along a horizontal line that was used as a scale, with 0 mm representing the worst and 100 mm representing the best. at the point that most accurately reflected their perceptions. General satisfaction, denture stability and retention, occlusion, comfort, ease of cleaning, ease of speaking, ease of chewing, bolus quality, and aesthetics

Secondary

MeasureTime frameDescription
prosthetic complicationsone yearThe complications include (1) complications of attachments: abutment fracture, abutment screw loosening, screw fracture, wear/distortion of retentive components, activation of retentive components, retention loss and replacement of retentive components, and separation of retentive components from the denture base, (2) technical complications of mandibular over-dentures: reline, fracture/remake, teeth wear, teeth separation/fracture, (3) technical complications of maxillary dentures: reline, fracture/remake, teeth wear, teeth separation/fracture, (4) Soft tis-sue complications of mandibular overdentures and maxillary dentures: mucositis, soreness, ulcer decubitus, hyperplasia, and flabbyridge

Countries

Egypt

Contacts

STUDY_CHAIRMarwa Aboelez, profesor

Mansoura University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026